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Virginia Bio periodically offers opinions on timely and important issues to the bioscience industry. You can find these published opinions provided within this blog.

 

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Top tags: bioscience  biotech  virginia bioscience  12st century cure  academic research  adial pharm  cel-sci  india trade  kaleo  morgan griffith  virginia economy 

Don’t Air Your Dirty Laundry

Posted By Administration, Friday, November 16, 2018

Virginia Bio and the UniFirst Corporation have teamed up to offer significant savings and benefits to member companies. Through the BIO Business Solutions® Program, Virginia Bio members have access to the highest quality garments and cleanroom services, complete with full Program Management. For more information, contact UniFirst today.

UniFirst Corporation that can offer savings of 30-50% on a wide selection of uniforms, lab coats, and other clothing items for rental programs or for direct purchase. The UniFirst partnership and benefits will also extend to program offerings from UniClean, a single-source provider for all cleanroom and controlled environment garment-related needs. Similar rental programs are also in place for facility service products and microfiber cleaning supplies.

Learn more about the program here!

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Griffith Brings Search For 21st Century Cures To Blacksburg

Posted By Administration, Monday, December 15, 2014
Updated: Tuesday, January 27, 2015
As published in the Roanoke Times on 12/15/2014 by Jeff Gallagher, CEO Virginia Bio

Rep. Morgan Griffith, R-Salem, recently invited a round table of leaders of the biomedical community in Southwest Virginia to gather ideas to support the work of the Energy and Commerce Committee, which he serves on, and the bipartisan 21st Century Cures Initiative.

Along with his colleague Rep. Phil Roe, M.D., (R-Tennessee) Griffith led, questioned and discussed ideas with academics, researchers, health care experts and biomedical company executives on how to revamp the federal laws and regulations that impact the discovery, development and delivery of cures and treatments to patients. This roundtable, hosted by Dr. Dixie Tooke-Rawlins, provost of the Edward Via College of Osteopathic Medicine, was one of many similar discussions conducted across the nation by members of the committee. Representatives from local companies Revivicor, BioTherapeutics, Teva and Health Diagnostic Laboratory participated, along with experts form Virginia Tech, Carilion and UVa.

The 21st Century Cures initiative deserves our applause. It’s a bipartisan effort to take a coherent look at the whole system, from drug discovery, to development to delivery, and the impact of the Food and Drug Administration, National Institutes of Health and other federal agencies. As a nation, we created and for the last 75 years have enjoyed the world’s greatest system for turning biomedical innovation into practice. To remain globally competitive and retain that leading position, we can and must improve to bring health and relief to more people more quickly and efficiently.

Industry experts here and around the nation have provided specific suggestions: greater involvement of patients, modernizing clinical trials and drug development, phaseless drug development, use of real world and post-approval data to support regulatory decision making, focusing special resources on key unmet medical needs, and preparing the FDA for the future.

I suggest in this long and intricate process keeping four points in mind.

The system is complex, robust but delicate. The system includes not only FDA and NIH, but also taxes, intellectual property rights, reimbursement systems and tort liability. Faster regulatory agencies in Europe have U.S. medical device firms taking their innovations to Europe first, and at rates accelerated by the new Medical Device Tax on revenues. Without strong intellectual property protection and affordable enforcement, no new drugs will be developed privately. Nor will innovative products be developed if the payor bureaucracy, private and public, has no codes to reimburse it.

Private investment and small business is essential. The private sector has a significant role in taking innovation through development to market. Smaller, more nimble companies are a key link in the chain, being closer to needs and closer to university sources of technology. Policymakers should support and extend the Small Business Innovation and Research program, which allocates a small percentage of federal research dollars to small companies, giving birth to great innovation, companies and jobs across the commonwealth. Before creating any new regulatory or paperwork burden, consider the impact on entrepreneurs and small companies.

One size need not fit all. Three decades ago, the Orphan Drug Act carved out rare diseases for special regulation, special path through FDA, and special market exclusivity. This policy has been a roaring success in development and marketing of drugs for unserved populations. Innovative approaches are required to address major needs such as antibiotic resistance, vaccines, and long-onset diseases such as Alzheimer’s. The breakthrough therapy designation is a recent example. Permitting and promoting collaboration among businesses and institutions would address challenges too big for any one entity.

Reinvigorate the system with fresh shared values. The system is set up to reward treatment for specific acute diseases, not for prevention or overall health, as evidenced by no federal payor reimbursement codes for prevention or early detection within the thousands for illness treatment. It’s set up to avoid risk at all cost, even if that means withholding promising experimental therapies from informed patients in need. FDA has discretion under current law to undertake many changes on its own; let’s get alignment to value innovation, prevention, wellness, flexibility and patient choice.

It is an important and timely endeavor that Griffith and his colleagues on both sides of the aisle are taking on. I am honored to serve as CEO of VirginiaBio, the statewide association of businesses, researchers and research institutions that invent, develop and commercialize biomedical innovation in Virginia. We pledge our support and wish them the best of success, for how they fare will impact the health, wellness and economic well-being of generations of Virginians to come.

Tags:  12st century cure  bioscience  biotech  morgan griffith  virginia bioscience 

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Academic Research Yields Impressive Returns

Posted By Administration, Saturday, October 25, 2014
Updated: Tuesday, January 27, 2015

As published in the Richmond Times-Dispatch on 10/25/2014 by Jeff Gallagher, CEO Virginia Bio


The research conducted at Virginia universities is a major contributor to the state’s economic development and a significant component of its higher-education enterprise.

Consider the raw economic impact: In 2012, research expenditures at Virginia public and private colleges and universities totaled $1.38 billion, according to the National Science Foundation. These expenditures support jobs and procure equipment, supplies and services from vendors across the state.

 

Research also generates innovation — new knowledge and technologies that translate into new products and processes — and gives birth to new jobs and companies.

I am honored to serve as CEO of Virginia Bio, the statewide association of companies and research institutions developing and commercializing bioscience innovation. I see the impact of academic research turned into economic activity every day as I crisscross the state and nation. It is no coincidence that the national centers of bio-entrepreneurship and commercial activity are located near the great research universities. The basic and translational research that universities perform is a spring of innovation and its commercialization contributes incalculably to the wealth, health and well-being of Virginians and people everywhere.

 

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Returns on investment in academic research can be calculated, and the yields are significant to investors, be they taxpayers or the private sector. In the early 2000s, Virginia’s public universities leveraged $13 million from the Commonwealth Technology Research Fund into $167 million — a better than 6:1 return on investment. Today, the University of Virginia reports that it leverages state funds into federal research funds at a ratio of 8:1. In recent years, industry has funded about 4 percent of the commonwealth’s academic research, an investment of more than $55 million annually, according to National Science Foundation data.

 

In June, the State Council of Higher Education for Virginia convened a summit on academic research. Gov. Terry McAuliffe welcomed more than 200 university researchers and administrators, industry executives and state and federal officials. The governor challenged them to think big and act boldly, because the breakthroughs that spring from university research will help drive our transition to a new Virginia economy.

 

Attendees heard that the major grantors of research funds — the National Institutes of Health, foundations and industry — increasingly favor collaborative proposals from groups of strong universities and public and private research centers/labs to attain world-class capabilities.

 

VirginiaBio members face this every day: high-tech, high-paying industries are globally competitive, and the market rewards collaborations that achieve excellence, be they private, public or mixed.

 

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Other states also understand this. The National Governors Association advises that academic research and development is an investment, and states must be strategic to compete. How? First, ascertain the research fields and assets in which the state’s universities excel, plus emerging fields in which they could excel, and support those in targeted, ongoing ways. Second, strongly encourage universities to work with one another and private and state partners to pursue major federal and private research-grant opportunities.

 

Over the past decade and through today, Virginia Bio has worked with members of the General Assembly and successive administrations as well as allies across the state to envision, enact and fund public policies that support an innovation economy driven by research: the Refundable R&D Tax Credit, the Commonwealth Research Commercialization Fund, state-match funds for Small Business Innovation Research awards, and the Angel Investor Tax Credit. Most recently, the Virginia Bioscience Health Research Corp. was created to facilitate Virginia public universities’ collaboration with one another and private industry on the commercial development of important research.

 

In the State Council of Higher Education for Virginia’s next statewide plan for higher education, I urge academic research be a priority. I encourage SCHEV, our elected representatives and our college and university leaders to think big and, as Governor McAuliffe urged at the summit, be creative and bold. Opportunity is at hand, but so is the risk of being passed by.

 

Virginia’s legacy of investment and vision is its outstanding research universities. I agree with state leaders who believe to secure our place in an increasingly globally competitive world, we should leverage these assets with public-private partnerships, multiuniversity research collaboration, and policies that make the translation of academic R&D to commercial reality a model to the nation.

In so doing, we can hasten the transformation to the new Virginia economy and make important contributions to our common wealth.

Tags:  academic research  bioscience  biotech  virginia bioscience 

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Biosciences Coming To Life In The Commonwealth

Posted By Administration, Sunday, September 14, 2014
Updated: Tuesday, January 27, 2015

As published in The Virginian-Pilot on 9/14/2014 by Jeff Gallagher, CEO Virginia Bio

In Richmond, biopharmaceutical researchers at Kaleo just won Food and Drug Administration approval on a treatment to rapidly reverse the effects of opioid overdose. In Vienna, scientists at CEL-SCI are working on a remarkable new cancer drug. In Charlottesville, ADial Pharmaceuticals is developing a medicine to reduce alcohol cravings.

These are just a few examples of extraordinary advances occurring in the commonwealth. Virginia lawmakers have been smart to support the bioscience industry through policies that encourage innovation.

The bioscience industry keeps our economy strong and our people healthy. But much more can be accomplished. This field is rapidly growing and changing, and our leadership - both in Virginia and the nation's capital - must ensure that government policy keeps pace.

Over the past few decades, medical breakthroughs have helped millions of Americans. Mortality rates for heart disease and cancer have fallen dramatically. New treatments are bringing relief to the chronically ill. Therapies for neurological diseases appear within grasp.

At the same time, the biopharmaceutical industry has boosted our nation's economy, supporting 3.4 million jobs nationwide and generating $789 billion in economic output.

That's the good news. The bad news is that as a nation we may be taking the biopharmaceutical sector's strength for granted.

In China, India and across Europe, governments are supporting companies to make huge research investments. A recent report by Battelle, a highly respected research organization, found that for the United States to maintain its leadership in biotech, the nation must support and improve policies that foster and reward innovation.

Biotech is a unique industry, both in its promise and its needs. It tends to grow in geographic clusters that offer a highly skilled workforce, access to research and capital, and effective government support.

Virginia is developing into one such cluster. Already, we have the sixth-highest concentration of technology workers in the nation.

In addition to established biotech companies, Virginia is home to numerous startups, many springing up from institutions like Eastern Virginia Medical School, Virginia Tech, the University of Virginia and George Mason, James Madison, Old Dominion and Virginia Commonwealth universities. Any one of these could deliver the next medical breakthrough.

In Virginia Beach, LifeNet Health Institute of Regenerative Medicine develops innovations including novel regenerative therapies. The Frank Reidy Research Center for Bioelectrics at ODU is pioneering the use of pulsed power technology in biomedicine, including new therapeutic delivery systems. EVMS research has contributed to the creation of at least 17 startups.

All of this development generates economic growth and jobs. Virginia's biopharmaceutical sector alone supports more than 76,000 jobs and $7.9 billion in annual economic output.

The rewards from biotech research can be huge. But developing a new drug isn't easy - it often takes 20 years and costs over $1 billion. Many promising ideas never pan out.

Thus, the biopharmaceutical sector spends more on research and development than any other manufacturing industry - including advanced sectors like semiconductors and aerospace.

Smart policies can narrow the gap between breakthrough discoveries and effective, commercially available treatments.

Policymakers need to maintain strong protections for intellectual property. Biotech innovators need to be able to recoup their enormous R&D investments before competitors can offer lookalike products.

A rigorous, transparent, but speedier regulatory approval process is also critical for patients and biotech innovators. The nation needs an environment free of delay unrelated to safety and efficacy.

Innovation depends on fair rules for the biggest single purchaser of medicines, the federal government. Some short-sighted cost-saving proposals, such as forcing pharmaceutical firms to rebate part of the sales price to government purchasers, would redirect much-needed investment dollars away from the industry, with the unintended consequence of hampering innovation.

With policy modernization, the United States could add more than 300,000 jobs in biotech by 2021.

Right now, the United States holds an edge in the innovation economy, and Virginia is on its way up. To keep moving, though, policymakers will need to be as innovative as the companies they're regulating.

Tags:  adial pharm  biotech  cel-sci  kaleo  virginia bioscience 

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India’s Protectionist Policies Harm Virginia’s Economy

Posted By Administration, Wednesday, October 16, 2013
Updated: Tuesday, January 27, 2015
As posted in the Jefferson Policy Journal on 10/16/2013 by Jeff Gallagher, CEO Virginia Bio

The next few years will be decisive for Virginia’s economy. According to a new report, Old Dominion’s job growth is expected to drop below the national average at least through 2014.

Virginia’s innovators, entrepreneurs and manufacturers are a powerful force at work to keep our state strong. To thrive, it is critical they have opportunity to compete in the global economy. Unfortunately, recent protectionist actions by a key Virginia trading partner and US ally -- the government of India -- threaten our state’s growing export economy and the thousands of jobs it supports.

Federal officials need to confront India’s discriminatory trade practices quickly and directly. Restoring a fair relationship between our two countries will preserve American jobs, help both our economies grow and put this long time strategic partnership on sounder footing.

Between 2009 and 2012, Virginia's exports have grown steadily from just over $15 billion to $18.2 billion. India, one of the world’s fastest growing economies, has emerged as a critical growth market for American goods. In 2011 alone, our state’s exports to India amounted to more than $284 million, an increase of 17 percent from the year before.

But in recent months, Indian officials have jeopardized this mutually beneficial trade relationship by discriminating against a wide range of goods invented, developed and manufactured in the United States and elsewhere outside India in a misguided attempt to bolster its own domestic producers.

Among the industries singled out for special protection is my industry bioscience, as well as energy and information technology -- three of Virginia’s most promising sectors.

According to a 2012 Battelle study, from 2007 to 2010 Virginia bioscience establishments grew at a rate that outpaced the in-state private sector by a better than five-to-one margin. During that same period, as Virginia’s private sector struggled with negative employment growth of -5.1 percent, our state’s bioscience sector posted 2.6 percent growth. The average annual wage I the bioscience sector in Virginia was nearly twice that in Virginia’s private sector. India’s practices threaten the success of this thriving industry.

In one example of unfair trade manipulation, the Indian government mandated that as much as 100 percent of all telecom and electronic equipment be sourced domestically. These “forced localization” requirements violate global trade rules and disadvantage countless Virginia businesses, particularly the 5,000 Virginia manufacturers that account for 230,000 jobs and 80 percent of state exports.

Presently, over 90,000 state jobs depend on shipments overseas. And 85 percent of Virginia exporters are small businesses, which add jobs at a faster rate than more mature businesses. Those employed by companies that export earn about 18 percent more than the national average wage. If exporters are forced to downsize, Virginia’s median family income may no longer be the country’s highest.

But India’s government is doing more than just keeping out U.S. goods -- it is also making it easier for Indian companies to steal intellectual property (IP) from foreign innovators. This should be of great concern to anyone interested in innovation, research and development driving economic growth and advances in human health. On a recent index comparing IP environments across countries, India ranked last on nearly every indicator.

In April, India’s Supreme Court denied a patent to a pharmaceutical firm for one of the firm’s most advanced cancer treatments, though it had been patented in over 40 other countries, including the US, China and Russia. India’s disregard for even basic IP protections undermines the incentives for all firms to invest in innovation. Over time, this will cost not only American industries such as bioscience, but Indian consumers as well.

So while India’s protectionism may benefit a few domestic firms in the short term, it will ultimately harm Indian citizens by raising prices and restricting consumer choice. By disregarding established trade norms, India discourages foreign investment and disrupts the supply chains on which its domestic businesses depend.

Putting an end to the Indian government’s destructive policies will require direct engagement by the federal government. Our leaders should make clear to Indian policymakers that, for the sake of both countries, India must respect its obligations as a U.S. trading partner.

Ending India’s unfair trade policies will bolster Virginia growth, innovation and job creation. When given a level playing field, state businesses have what it takes to compete and prosper, and to create, invest, develop and share the fruits of their efforts in the global economy.

Tags:  bioscience  india trade  virginia economy 

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